Novel prefilled syringe for aflibercept may raise transient vision loss risk

A recent study comparing the use of a novel prefilled syringe (PFS) and the established vial system (VS) for intravitreal aflibercept application found a more than 5-fold increased risk of transient vision loss (TVL) associated with the use of the PFS. The study, conducted over a four-month period, found that patients using the PFS had a 5.3-fold higher risk of experiencing TVL compared to those using the VS.

The study involved the analysis of 1720 intravitreal injections of aflibercept administered to 672 patients. The observation period included 2 months prior to the introduction of the PFS and 2 months afterward. TVL was defined as the loss of perception of hand motion for a duration exceeding 30 seconds.

Results from the study found that of the 842 injections administered with the old VS, TVL occurred in 2 instances (0.24%) affecting 2 patients. In contrast, the novel PFS saw 11 cases of TVL (1.25%) in 10 patients. The statistical analysis indicated a significant difference between the systems.

Patients using the PFS were found to have a 5.3-fold increased risk of TVL compared to those using the VS (odds ratio: 5.33; 95% confidence interval: 1.2-24.1; P = 0.0298).

Reference
Klaas JE, Bui V, Maierhofer N, et al. Risk of transient vision loss after intravitreal aflibercept using vial-prepared vs. the novel prefilled syringe formulation. Front Med (Lausanne). 2023;10:1295633. doi: 10.3389/fmed.2023.1295633. PMID: 37954554; PMCID: PMC10634539.